INTEGRATE II, an AGITG led Phase III clinical trial in gastro-oesophageal cancer has opened to recruitment in Australia.  The first patient on the study was recruited at Townsville Hospital, QLD. Other active Australian sites include Gosford Hospital, NSW, and the Royal North Shore Hospital, NSW.   Korean sites will be initiated in early December and are anticipated to open in mid-December. Both Japan and Taiwan sites will open next year.

There currently exist few effective treatment options for patients with Advanced Gastro-Oesophageal Cancer (AGOC) that has returned after surgery or where it is incurable (metastatic) at diagnosis.  Chemotherapy can be effective at first, but once the cancer has become resistant to it, the options for treatment are limited.   A second course of a different chemotherapy (docetaxel or irinotecan) can prolong survival, but not all patients are fit to receive this treatment.   For those who do receive a second course, their cancer will eventually become resistant (or “refractory”) to these drugs.   In both of these situations, there are currently no accepted treatment options that have been shown to be both effective against the cancer and tolerable for patients.   Better treatment options are urgently needed.

Regorafenib (BAY 73-4506) is a ‘multi-targeted therapy’ targetting a number of different signals in the cancer cell that cause it to grow and produce blood vessels.  In other cancers such as colon cancer and GIST, regorafenib has been proven to be of benefit when other drugs have ceased to work. The Phase II trial – INTEGRATE, demonstrated efficacy with the use of regorafenib in AGOC, and could potentially become a new standard of care after other therapeutic agents have stopped working. INTEGRATE II is being undertaken to confirm the findings of the Phase II trial in a larger population.

If the study is positive it will provide evidence for regorafenib as a new standard of care after other treatments no longer benefit patients with gastric cancer.

“It is very exciting to be involved with such a great research team in developing and leading an international Phase II and now Phase III   trial, (INTEGRATE II) for patients with advanced gastric cancer,” said Associate Professor Nick Pavlakis, Study Chair, INTEGRATE II. “We hope that at the conclusion of the  INTEGRATE II trial, we will have definitive results on the use of regorafenib to extend people’s lives with this cancer.”

350 patients will be recruited from sites in Australia, New Zealand, Asia, and North America (233 to receive regorafenib; 117 to receive placebo).  Half of these patients will be recruited in Asia to determine whether Asian ethnicity itself is associated with greater benefit (175 are planned to be recruited from Asia).

For more information about this trial please  click here